Email, SMS and direct-message marketing for digital health products in Canada

Start with Canadian market authorisation

Regulator guidance

Advertising eligibility depends on the product’s Canadian regulatory status and authorised uses. Health Canada describes independent preclearance as generally voluntary, with specific exceptions such as opioid advertising; do not label every campaign as legally subject to mandatory preclearance.

Sources: Advertising requirements for drugs and medical devices

Review the exact health-product classification

Regulator guidance

For a Class II, III or IV device, Medical Devices Regulations section 27 generally requires the manufacturer’s device licence or amended licence before advertising for sale. A limited catalogue exception requires the specified clear warning; it is not a general consumer-campaign exemption.

Separate the device licence from establishment licensing and verify the advertised model and intended use. A laboratory service or health app also needs its own classification assessment.

Sources: Advertising requirements for drugs and medical devices; Distinction between advertising and other activities: legislative and regulatory provisions · Health Canada legislative excerpts: Medical Devices Regulations section 27

Check the complete consumer-facing message

Regulator guidance

Competition Act provisions address materially false or misleading promotion of products, services and business interests. The assessment considers literal meaning and general impression, including images and omitted conditions. Review professional titles, claimed outcomes and conditional prices with the same care as the headline.

Sources: False or misleading representations

Check CASL before sending commercial electronic messages

Regulator guidance

Commercial email and text messages generally need an express or qualifying implied consent basis, identification information and a working unsubscribe mechanism. Document the applicable conditions and expiry of any implied consent; a message asking for consent can itself be commercial.

Sources: Canada’s anti-spam legislation: FAQs

Calculate implied-consent expiry for each recipient

Regulator guidance

For the existing-business-relationship route, qualifying purchases generally support two years of implied consent; qualifying enquiries or applications support six months. A qualifying written contract may support consent while in force and for two years after expiry. These periods do not replace the conditions of the particular route. Express consent has no fixed expiry but can be withdrawn; honour unsubscribe requests within ten business days and keep proof of the basis used.

Sources: CASL implied-consent periods

Quebec: review French content and signage separately

Regulator guidance

Applies when: Quebec commercial-language rules apply to the business and execution.

Businesses operating in Quebec must provide French commercial publications, including a complete French website and French social-media content, subject to applicable exceptions. Public signage and commercial advertising have a distinct French-predominance regime. Review the rules effective from 1 June 2025 for trademarks and business names on signage; a bilingual website alone does not resolve an exterior sign.

Sources: French-language rights in commerce; Business names and trademarks on signage

Separate promotional and service messages

Editorial recommendation

Review the rules for the actual delivery method: email, SMS and private social messages are not interchangeable. Keep the relevant permission record, accurate sender details and a working suppression process.

A public email address is not unrestricted marketing permission

Regulator guidance

CRTC describes a narrow conspicuous-publication route: there must be no statement refusing commercial messages and the message must relate to the recipient’s business role, functions or duties. Document the actual basis instead of treating a scraped address as blanket consent.

A stop request must be respected within ten business days regardless of the original consent type. Keep the contact-permission assessment separate from health-data and professional restrictions.

Sources: CRTC — CASL guidance on implied consent

Digital Health Products: prepare the review

Editorial recommendation

Classify each software function separately: lifestyle, medical software or delivery of care. Link accuracy and clinical outcome claims to the advertised software version and population. Review tracking and marketing data flows separately from permission to provide care.

Keep a traceable campaign decision

Editorial recommendation

Keep one review record linking the offer, local market status, claim evidence, exact creative, media settings and any regulatory or professional clearance. Record who checked each condition. Reopen the review when the offer, claim, source rule or execution changes.